US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.
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Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.
CDER compliance office director Donald Ashley offers a cautionary note to temper expectations for the FDA’s enforcement in the supplement sector. “We continue to warn the public about products very often sold as dietary supplements that contain hidden drugs,” he says.